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The Synthes Trochanteric Fixation Nail- Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Specifically the system is indicated for:

• Stable and unstable pertrochanteric fractures
• Intertrochanteric fractures
• Basal neck fractures
• Combinations of pertrochanteric, intertrochanteric, and basal neck fractures
  The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12- 21) in which the growth plates have fused for the following indications:
• Subtrochanteric fractures
• Pertrochanteric fractures associated with shaft fractures
• Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions
• Long Subtrochanteric fractures
• Proximal or distal non-unions, malunions and revisions
  Both the short and long TFNA systems are additionally indicated for use with cleared polymethylmethacrylate (PMMA) bone cement that can be delivered through the fenestrated blade or screw via a cannula in skeletally mature adults with risk of cut-out or device instability due to poor bone quality.

The DePuy Synthes TFNA Augmentation System consists of components to the predicate DePuy Synthes TFNA System with added perforations to the femoral head elements. The perforations enable the delivery of cleared PMMA bone cement(s) to be delivered through the helical blade/femoral neck screw in patients with poor bone quality and/or increased risk of fixation failure at the implant/bone interface.
The materials of manufacture are the same as those used to manufacture the predicate TFNA hardware: Ti-15Mo (ASTM F-2066); Ti-6Al-7Nb (ASTM F1295); 40Co-20Cr-16Fe-15Ni-7Mo (ASTM F1058)

The provided document is a 510(k) premarket notification for the DePuy Synthes TFNA Augmentation System. It does not describe a study involving an AI/machine learning device or model; instead, it concerns a physical medical device (an intramedullary fixation rod). Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies proving the device meets those criteria, particularly in the context of AI/ML performance.

The document discusses substantial equivalence to a predicate device based on:

• Similar intended use, indications, design characteristics, functionality, materials, and performance.
• Dynamic fatigue testing comparing fenestrated and non-fenestrated head elements.
• Biomechanical evaluation of cut-out resistance.
• Evaluations to confirm the ability of the fenestrated hardware to deliver bone cement in a controlled and predictable manner (flow patterns, extraction validations).

Since the request focuses on acceptance criteria and a study for an AI device, and this document pertains to a physical orthopedic implant, I cannot extract the requested information.

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